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Testing whether balanced iv fluids are better than normal saline for treating adults with diabetic ketoacidosis in the Emergency Department

Balanced crystalloids versus normal saline efficacy in adults with diabetic ketoacidosis in the emergency department: prospective single blind randomized controlled superiority trial. - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/12/099219
Enrollment
200
Registered
2025-12-16
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E101- Type 1 diabetes mellitus with ketoacidosis

Interventions

Intervention1: Balanced crystalloids ( Ringers lactate): Ringers lactate as only fluid in DKA management both in resuscitation and maintenance fluid. For the duration of 12 months Control Intervention

Sponsors

Tarun Rana
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult patient more than or equal to 18 years of age has clinical criteria satisfying for DKA. blood glucose more than 200 Anion gap more than 10mmol per lit Bicarbonate level less than 18 Presence of beta hydroxy butyrate or ketone in blood or urine

Exclusion criteria

Exclusion criteria: Patient received treatment from outside facility in form of iv fluids more than 1 litre. Refered TO AIIMS for further care only. Had euglycemic DKA

Design outcomes

Primary

MeasureTime frame
Time of resolution of DKA from starting of treatment. Its based on lab criteria, pH7.35 bicarbonate 18 meq/litTimepoint: To find the time of DKA resolution, patient will be assessed every 2 hourly with venous blood gas.

Secondary

MeasureTime frame
To compare time to insulin pump discontinuation (hours) To compare electrolyte abnormalities including hyperkalemia, hypokalemia & hyperchloridemia. To compare intensive care unit admission & length of hospital stay. To compare total length of hospital stay. To compare in hospital all cause mortality To compare in hospital acute kidney injury. To compare major adverse kidney event within 30 daysTimepoint: With in 4 weeks

Countries

India

Contacts

Public ContactDr Bharat Bhushan Bhardwaj

Aiims Rishikesh

bharat.em@aiimsrishikesh.edu.in7800001352

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026